pCPA Panel

On Tuesday, June 13, 2017, the Canadian Association for Healthcare Reimbursement (CAHR) held the Market Access 201 conference in Toronto. The theme for this conference was Parallel or Intersecting Paths, the Future of Public and Private Reimbursement in Canada which consisted of five fascinating panels focusing on key topics of interest to the Canadian pharmaceutical stakeholders. Over the past several weeks, MORSE has been releasing summaries for each panel to share key learnings from this conference. This fifth and final issue will focus on the pan-Canadian Pharmaceutical Alliance (pCPA) panel discussion.

Session Topic: pan-Canadian Pharmaceutical Alliance

Description: This panel focused on recent events surrounding the pCPA and the results of an analysis on implicit prioritization of negotiations. The presentation was followed by a discussion that included a representative from the pCPA Office and a public payer to solicit their views on latest activities at the pCPA and how they saw the future evolving.

Speakers:

Judy McPhee, Former Executive Director of Pharmaceutical Services and Extended Health Benefits with the Nova Scotia Department of Health and Wellness

Sherry O’Quinn, Managing Principal, MORSE Consulting (MODERATOR)

Summary:

Angela Rocchi, Athena Research

This study looks at pCPA activities and implicit prioritization analysis. It is unfunded and we have no conflicts to declare. The whole negotiations process started off with the expedient need of the provinces to manage the pricing and market access using the PLA tools and evolved organically. There is more formality now. The decisions that get made reflect implicit prioritization, so the analysis examines this and also looks at the role of health economics.

With regards to the data, there were some missing dates and we sought those dates from individual manufacturers. We looked at what the pCPA has completed and looked backwards at the HTA recommendations. The primary limitation is that the pCPA archives were not designed for scientific research. A few of the “do not list” recommendations were not negotiated but were not in the archive including 3 from the early years. All of the drugs are included but not necessarily all of the indications. We excluded active files which were largely from 2016.

This left 171 drug indications to look at. Only one HTA Recommendation was considered for each negotiated indication. If there was more than one round of negotiation, we only included the latest and excluded earlier rounds which tended to be longer and less often unsuccessful. We included submission variables, economic variables and time variables.

“In consideration” was the primary metric for prioritization and is defined as the time between HTA recommendation and the start of negotiations. The same proportion of drugs ends up being negotiated whether arising from the CDR or pCODR.

My Initial reaction is that there is a lot of information there and obviously I’ve seen a little bit of it but have not spent the time to assess it thoroughly. The analysis is raising good questions to identify potential patterns in the negotiations process. The pCPA Office is also working to analyze the process through data. I look forward to spending some time reviewing with my team and provide feedback to your analysis as well.

pCPA does not employ a formal prioritization mechanism currently. The result of that is that the pCPA process is trying to move every file forward all the time. The assumption that when something is “not important” it gets put aside, is an assumption I would challenge. Nothing gets put aside, and that is part of the challenge.

It should be noted that the sample size is only 171 negotiations. I wish we could draw nice straight-line conclusions but often times we are looking at 7 or 8 or fewer instances and are inferring a “trend”. That being said, we can look at the data that is emerging and perhaps gain insight into any implicit prioritization.

In terms of linking the “importance” of a file to time to initiate negotiations, thinking offhand, there are often times a file could be identified as “important” and it can spend either a little time or a lot of time in consideration; the same holds true for “not important” files. There are a multitude factors that impact time to initiate negotiations, including that the pCPA is a collective and the jurisdictions need to come to a common set of objectives before engaging in effective negotiations.

The “in consideration” phase is more of a terminology change than a process change; earlier on in pCPA’s evolution, pCPA would not spend time upfront establishing common objectives and would engage manufacturers and then conduct the same process of establishing common objectives amongst pCPA jurisdictions under the categorization of an “active negotiation.”

There is an opportunity to understand more as the 171 continues to grow.

Judy McPhee, Former Executive Director of Pharmaceutical Services and Extended Health Benefits with the Nova Scotia Department of Health and Wellness

Disclaimer: Is giving thoughts about the subject as a former drug plan manager and participant in pCPA and not speaking on behalf of the Drug Plans, pCPA or NS government.

I would echo Imran’s comments. I’m not surprised by any of it. Drugs that go through with a positive recommendation can take time to get through. I think before a Yes was a Yes however as budgets get tighter affordability is considered and that factors in as well. Drug plans are trying to figure out what they want to get before hand.

When you have 19 individuals trying to figure it out it can take some time. I think prioritization is going on naturally. A Positive recommendation gives you a card to negotiate but it is no longer a guaranteed listing. Drug plans are no longer just looking at that drug and the budget for 1 year. They are looking a few years down the road. You are not just competing in that class you’re competing in the whole space.

I think there should be formal prioritization as budgets get smaller, and money should be put where the biggest bang for the buck is or where the priorities are. Once the money runs out you cannot add more drugs. You reach a stage where choices must be made… these are the ones that have LOIs so which ones should be added in this budget cycle. For example a drug for Fifth line breast vs. a drug for melanoma which has few options and so that prioritization can take place.

QUESTIONS

One of those things that jumped out to me, was the difference for oncology. There are many reasons they may be different compared to CDR, is that actually a sign that oncology drugs are prioritized or a sign of other factors?

JM: I think it’s a resource issue. I think oncology drugs are not in consideration as long. With non-oncology drugs you have all of the drug plans deciding which to take on and with oncology you have the cancer agencies. I don’t think it’s any prioritization that pCPA is doing. Cancer budgets are separate and generally not lumped in with all the other CDR drugs. Agencies do a lot of the negotiations.

IA: I would agree, there are other people involved in oncology negotiations – i.e. the cancer agencies. Scott Gavura from Cancer Care Ontario could speak to rate of spending increase in oncology compared to other areas over the years. Tends to be higher on cancer side which may create a more flexible environment for negotiations. The cancer world is starting to look more like the rest of the space as well in terms of restricted budget growth.

SO: Different process, with different implementation and you might expect to see some differences.

In the early days of CDR there was a lot of discussion about timelines and process and many changes have been made over the years in response to critiques. One of the things is that companies don’t see a process as such with pCPA – there is too much uncertainty around pCPA. Whereas they know CDR well. What process items could you put in place which puts more confidence for manufacturers in that their file may move forward?

IA: When you look at the big picture and see what the public drug plans are trying to accomplish with these negotiations – during that 1 year they are trying to get the price point and other terms correct that will apply for 10+ years. One example could be, it might help alleviate the pressure on the process upfront if there is a way to build in a re-assessment of the outcomes of the negotiations after a few years. It is also important to have target timelines for the process as well and we currently don’t have those in place.

JM: Not sure about targets, some of the long timelines are due to with whoever happens to be negotiating that file and they may have 5 or 6 on the go as well as how far apart the two sides are on price. Maybe after drug plans have come up with what they are looking for it could be more transparent. Close them out faster i.e. if you are not coming to a conclusion may be a better to close that file with an understanding it can always be reopened if circumstances change.

Could you please comment on the Minister’s note on capacity?

IA: Looking at the entire Canadian drug approval and reimbursement scheme, there is recognition that pCPA is valuable and there is a commitment to do it better. Additional resourcing is valuable, and will help some things but it is not a silver bullet. The reality is those public drug plan budgets are not impacted by increased negotiations capacity.

What is the key take-away for manufacturers from your research?

AR: When we look at the metrics for success the number 1 predictor is getting a Yes at the HTA level and focus on the clinical story. It drives the economic story as well.

With respect to the ICER, I feel a bit stifled as someone who develops model by the lack of communication and ability to understand what goes on in the opposing heads. It is simpler on the clinical side and greater understanding of the right way of doing things. This does not exist on the economic side. More communication between manufacturer and HTA agency can improve the usefulness of the economic review component. It may take a number of years to adjust to new guidelines.

One of the gaps is the lack of an end to end document, not referring to target timelines, what is the flow of the process? Is there a plan to provide a document with all the steps?

IA: With regards to process guidelines, there were consultations last year. We are looking at a Fall 2017 timeline for a document that outlines the pCPA brand negotiations process. This document is not going to capture all the things that happen during a negotiation but should capture 80% of the process.

MORSE thanks our Reimbursement Strategist, Avery Hughes, for diligently preparing these summary notes during the conference and the panel members for their review of the draft. This summary is not an official transcript of the presentations/ discussions – as such, it may contain some errors/omissions/misinterpretations. Please contact the pCPA Office, Judy McPhee, Angela Rocchi or Sherry O’Quinn if you would like additional information or clarification on this topic.